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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD091972 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The purpose of this clinical trial is to investigate the effectiveness of vasopressin nasal spray for treating symptoms associated with autism. Vasopressin is a hormone that is produced naturally within the body and has been implicated in regulating social behaviors. It has been proposed that administration of the hormone may also help improve social functioning in individuals with autism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vasopressin-Vasopressin | Experimental | 8 weeks of vasopressin nasal spray (16 international units twice daily) |
|
| Placebo-Vasopressin | Experimental | 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily) |
|
| Placebo-Placebo | Placebo Comparator | 8 weeks of placebo nasal spray; followed by a 4 week open-label extension of vasopressin nasal spray (16 international units twice daily) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vasopressin (USP) Injectable Solution [Vasostrict] | Drug | Nasal Spray |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | Social Responsiveness Scale, 2nd Edition (SRS) scores measure social abilities with lower scores meaning better social abilities. The SRS-2 is reported as a total score (T-Score Range: 37 to above 90), and the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5-compatible Social Communication and Interaction (SCI) score (T-Score Range: 36 to above 90) and Restricted Interests and Repetitive Behavior (RRB) score (T-Score range: 41 to above 90). A T-score of 50 indicates the population mean with a standard deviation of 10. Higher scores correspond to greater symptom levels (≤ 59: within normal limits; 60-65: mild range; 66-75: moderate range; ≥ 76: severe range). Change is reported as 4-week minus the baseline score, and 8-week minus the 4-week score. For this outcome, the baseline score is the average of the screening visit and baseline visit (average approximately 2 to 3 weeks after the screening visit). | baseline, 4-week, 8-week |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. | Clinician assessment of CGI severity (CGI-S) and CGI improvement (CGI-I) scores.
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Vasopressin Concentration Predicting Primary and Secondary Behavioral Outcome Measures. | 4-week; 8-week | |
| Change From Baseline in Vineland Adaptive Behavior Scales, Third Edition (VABS-3) - Social Skills and Relationships Domain During Treatment. | 4-week; 8-week |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Y. Hardan, M.D. | Stanford University | Principal Investigator |
| Karen J. Parker, Ph.D. | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305-5719 | United States |
National Database for Autism Research (NDAR) Submission per NIH requirements
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323 participants were screened. 157 participants signed informed consent, and 108 were randomized.
Participants were randomized to one of three groups for two 4-week treatment periods. Participants in the Placebo-Placebo group were given the opportunity to enroll in a 4-week open-label extension period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vasopressin-Vasopressin | 8 weeks of vasopressin nasal spray (16 international units twice daily) |
| FG001 | Placebo-Vasopressin | 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily) |
| FG002 | Placebo-Placebo | 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (4 Weeks) |
| ||||||||||||||||
| Treatment Period 2 (4 Weeks) |
| ||||||||||||||||
| Open-label Extension (4 Weeks) |
|
Participants who were randomized and treated (received intervention)
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| ID | Title | Description |
|---|---|---|
| BG000 | Vasopressin-Vasopressin | 8 weeks of vasopressin nasal spray (16 international units twice daily) |
| BG001 | Placebo-Vasopressin | 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Total Scores During Treatment. | Social Responsiveness Scale, 2nd Edition (SRS) scores measure social abilities with lower scores meaning better social abilities. The SRS-2 is reported as a total score (T-Score Range: 37 to above 90), and the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5-compatible Social Communication and Interaction (SCI) score (T-Score Range: 36 to above 90) and Restricted Interests and Repetitive Behavior (RRB) score (T-Score range: 41 to above 90). A T-score of 50 indicates the population mean with a standard deviation of 10. Higher scores correspond to greater symptom levels (≤ 59: within normal limits; 60-65: mild range; 66-75: moderate range; ≥ 76: severe range). Change is reported as 4-week minus the baseline score, and 8-week minus the 4-week score. For this outcome, the baseline score is the average of the screening visit and baseline visit (average approximately 2 to 3 weeks after the screening visit). | Participants with available data at the respective time point | Posted | Least Squares Mean | Standard Error | T-score | baseline, 4-week, 8-week |
UP to 12 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vasopressin-Vasopressin Group - Treatment Period 1 | Adverse events occurring in the Vasopressin-Vasopressin group during the first 4-week treatment period (while receiving active drug). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Antonio Hardan, MD | Stanford University | (650)736-1235 | autismdd@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 27, 2020 | Jul 8, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 17, 2023 | Jul 8, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 12, 2023 | May 1, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D014667 | Vasopressins |
| D001127 | Arginine Vasopressin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
Not provided
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| Placebo | Drug | Placebo Nasal Spray |
|
| baseline; 4-week; 8-week |
| Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment. | Score range: 0 to 28; higher scores mean better ability to read emotions and lower scores mean worse ability to read emotions. | baseline; 4-week; 8-week |
| Change From Baseline on the Facial Emotion Recognition Test During Treatment. | Score range: 0 to 42; higher scores mean better facial emotion recognition abilities. Lower scores mean worse facial emotion recognition abilities. | baseline; 4-week; 8-week |
| Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment. | Score range: 0 to 129; higher scores on the RBS-R mean higher levels of repetitive and restricted behaviors. | baseline; 4-week; 8-week |
| Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. | Scale measuring severity of anxiety symptoms. Score range: 0 to 114; higher scores mean higher levels of anxiety, lower scores mean lower levels of anxiety. | baseline; 4-week; 8-week |
| Change From Baseline on Electrocardiogram (EKG) P Duration During Treatment. | baseline to 4-week, 8-week, and 12-week |
| Change From Baseline on Electrocardiogram (EKG) PR Interval During Treatment. | baseline to 4-week, 8-week, and 12-week |
| Change From Baseline on Electrocardiogram (EKG) QRS Interval During Treatment. | baseline to 4-week, 8-week, and 12-week |
| Change From Baseline on Electrocardiogram (EKG) QT Interval During Treatment. | baseline to 4-week, 8-week, and 12-week |
| Change From Baseline on Blood Clinical Labs (Sodium) During Treatment. | baseline to 4-week, 8-week, and 12-week |
| Change From Baseline on Blood Clinical Labs (Potassium) During Treatment. | baseline to 4-week, 8-week, and 12-week |
| Change From Baseline on Blood Clinical Labs (Chloride) During Treatment. | Change from baseline on blood clinical labs (Chloride) during treatment. | baseline to 4-week, 8-week, and 12-week |
| Change From Baseline on Blood Clinical Labs (CO2) During Treatment. | baseline to 4-week, 8-week, and 12-week |
| Change From Baseline on Blood Clinical Labs (Anion Gap) During Treatment. | baseline to 4-week, 8-week, and 12-week |
| Change From Baseline on Blood Clinical Labs (Glucose) During Treatment. | baseline to 4-week, 8-week, and 12-week |
| Change From Baseline on Blood Clinical Labs (Creatinine) During Treatment. | baseline to 4-week, 8-week, and 12-week |
| Change From Baseline on Blood Clinical Labs (Urea Nitrogen) During Treatment. | baseline to 4-week, 8-week, and 12-week |
| Change From Baseline on Blood Clinical Labs (Calcium) During Treatment. | baseline to 4-week, 8-week, and 12-week |
| Change From Baseline on Blood Clinical Labs (Osmolality) During Treatment. | baseline to 4-week, 8-week, and 12-week |
| Change From Baseline on Urine Clinical Labs (Osmolality) During Treatment. | baseline to 4-week, 8-week, and 12-week |
| Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. | Up to 12 weeks |
| Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. | Up to 12 weeks |
| Change From Baseline on Vital Signs (Pulse) During Treatment. | Up to 12 weeks |
| Change From Baseline on Height During Treatment. | baseline to 4-week, 8-week, and 12-week |
| Change From Baseline on Weight During Treatment. | baseline to 4-week, 8-week, and 12-week |
| Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | The DOTES evaluates a subset of symptoms related to various medical conditions. The clinician assesses intensity (0=Not assessed, 1=Not present, 2=Mild, 3=Moderate, 4=Severe), relatedness (0=None, 1=Remote, 2=Possible, 3=Probable, 4=Defined), and action taken (0=None, 1=Increased , 2=Contractive Rx, 3=Change Dose, 4=Change Dose Plus Contractive Rx, 5=Suspend Rx, 6=Discontinue Rx). Side effects are included that have increased in severity, become more likely to be related, or require action. Change from baseline is reported as the number of participants with change in these side effects during treatment. | Up to 12 weeks |
| Number of Participants Reporting Aggression Using the Overt Aggression Scale (OAS) During Treatment. | The scale evaluates the child participant's aggression. The number of children who exhibited aggression as reported by the parent is reported. | baseline, 4-weeks, 8-weeks |
| Adverse Event Severity | Adverse events collated according to intensity for each pre-allocated treatment group. | Up to 12 weeks |
| Change From Baseline in Parent Rated Pediatric Quality of Life (PedsQL) Inventory Scores During Treatment. | 4-week; 8-week |
| Change From Baseline on Eye Gaze Assessment (Eye Tracking) During Treatment. | 4-week; 8-week |
| Change From Baseline on the Developmental Neuropsychological Assessment, Second Edition (NEPSY-II) Theory of Mind Test During Treatment. | 4-week; 8-week |
| Change From Baseline the Diagnostic Analysis of Nonverbal Accuracy, Second Edition (DANVA-2) Child Voices Prosody Test During Treatment. | 4-week; 8-week |
| Change From Baseline in Parent Rated Stanford Social Motivation Scale (Also Known as the Stanford Social Dimensional Scale) Total Scores During Treatment. | 4-week; 8-week |
| Change From Baseline in Parent Rated Anxiety Scale - Autism Spectrum Disorder (PRAS-ASD) Score During Treatment. | 4-week; 8-week |
| Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Social Avoidance Factor Score During Treatment. | 4-week; 8-week |
| Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Emotion Recognition Factor Score During Treatment. | 4-week; 8-week |
| Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Interpersonal Relatedness Factor Score During Treatment. | 4-week; 8-week |
| Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Insistence On Sameness Factor Score During Treatment. | 4-week; 8-week |
| Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Repetitive Mannerisms Factor Score During Treatment. | 4-week; 8-week |
| Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Attachment and Affiliation Factor Score During Treatment. | 4-week; 8-week |
| Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Non-facial Communication Production Factor Score During Treatment. | 4-week; 8-week |
| Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Facial Communication Production Factor Score During Treatment. | 4-week; 8-week |
| Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Mental States Understanding Factor Score During Treatment. | 4-week; 8-week |
| Change From Baseline in Parent Rated Child's Sleep Habits Questionnaire (CSHQ) Score During Treatment. | 4-week; 8-week |
| Change From Baseline on Spectral Power in the Alpha, Theta, and Gamma Frequencies as Measured by Electroencephalogram (EEG) During Treatment. | 4-week; 8-week |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Placebo-Placebo | 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Vasopressin-Vasopressin | 8 weeks of vasopressin nasal spray (16 international units twice daily) |
| OG001 | Placebo-Vasopressin | 4 weeks of placebo nasal spray followed by 4 weeks of vasopressin nasal spray (16 international units twice daily) |
| OG002 | Placebo-Placebo | 8 weeks of placebo nasal spray; followed by a 4 week optional open-label extension of vasopressin nasal spray (16 international units twice daily) |
|
|
| Secondary | Change From Baseline in Clinical Global Impression (CGI) Scores During Treatment. | Clinician assessment of CGI severity (CGI-S) and CGI improvement (CGI-I) scores.
| Participants with data at the respective time point | Posted | Least Squares Mean | Standard Error | score on a scale | baseline; 4-week; 8-week |
|
|
|
| Secondary | Change From Baseline on Reading the Mind in the Eyes Test (RMET) During Treatment. | Score range: 0 to 28; higher scores mean better ability to read emotions and lower scores mean worse ability to read emotions. | Participants with data at the respective time point | Posted | Least Squares Mean | Standard Error | score on a scale | baseline; 4-week; 8-week |
|
|
|
| Secondary | Change From Baseline on the Facial Emotion Recognition Test During Treatment. | Score range: 0 to 42; higher scores mean better facial emotion recognition abilities. Lower scores mean worse facial emotion recognition abilities. | Participants with data at the respective time point | Posted | Least Squares Mean | Standard Error | score on a scale | baseline; 4-week; 8-week |
|
|
|
| Secondary | Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment. | Score range: 0 to 129; higher scores on the RBS-R mean higher levels of repetitive and restricted behaviors. | Participants with data at the respective time point | Posted | Least Squares Mean | Standard Error | score on a scale | baseline; 4-week; 8-week |
|
|
|
| Secondary | Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment. | Scale measuring severity of anxiety symptoms. Score range: 0 to 114; higher scores mean higher levels of anxiety, lower scores mean lower levels of anxiety. | Participants with data at the respective time point | Posted | Least Squares Mean | Standard Error | score on a scale | baseline; 4-week; 8-week |
|
|
|
| Secondary | Change From Baseline on Electrocardiogram (EKG) P Duration During Treatment. | Participants with available data at the respective time point | Posted | Mean | Standard Deviation | milliseconds | baseline to 4-week, 8-week, and 12-week |
|
|
|
| Secondary | Change From Baseline on Electrocardiogram (EKG) PR Interval During Treatment. | Participants with available data at the respective time point | Posted | Mean | Standard Deviation | milliseconds | baseline to 4-week, 8-week, and 12-week |
|
|
|
| Secondary | Change From Baseline on Electrocardiogram (EKG) QRS Interval During Treatment. | Participants with available data at the respective time point | Posted | Mean | Standard Deviation | milliseconds | baseline to 4-week, 8-week, and 12-week |
|
|
|
| Secondary | Change From Baseline on Electrocardiogram (EKG) QT Interval During Treatment. | Participants with available data at the respective time point | Posted | Mean | Standard Deviation | milliseconds | baseline to 4-week, 8-week, and 12-week |
|
|
|
| Secondary | Change From Baseline on Blood Clinical Labs (Sodium) During Treatment. | Participants with available data at the respective time point | Posted | Mean | Standard Deviation | mmol/L | baseline to 4-week, 8-week, and 12-week |
|
|
|
| Secondary | Change From Baseline on Blood Clinical Labs (Potassium) During Treatment. | Participants with available data at the respective time point | Posted | Mean | Standard Deviation | mmol/L | baseline to 4-week, 8-week, and 12-week |
|
|
|
| Secondary | Change From Baseline on Blood Clinical Labs (Chloride) During Treatment. | Change from baseline on blood clinical labs (Chloride) during treatment. | Participants with available data at the respective time point | Posted | Mean | Standard Error | mmol/L | baseline to 4-week, 8-week, and 12-week |
|
|
|
| Secondary | Change From Baseline on Blood Clinical Labs (CO2) During Treatment. | Participants with available data at the respective time point | Posted | Mean | Standard Error | mmol/L | baseline to 4-week, 8-week, and 12-week |
|
|
|
| Secondary | Change From Baseline on Blood Clinical Labs (Anion Gap) During Treatment. | Participants with available data at the respective time point | Posted | Mean | Standard Error | mmol/L | baseline to 4-week, 8-week, and 12-week |
|
|
|
| Secondary | Change From Baseline on Blood Clinical Labs (Glucose) During Treatment. | Participants with available data at the respective time point | Posted | Mean | Standard Error | mg/dL | baseline to 4-week, 8-week, and 12-week |
|
|
|
| Secondary | Change From Baseline on Blood Clinical Labs (Creatinine) During Treatment. | Participants with available data at the respective time point | Posted | Mean | Standard Error | mg/dL | baseline to 4-week, 8-week, and 12-week |
|
|
|
| Secondary | Change From Baseline on Blood Clinical Labs (Urea Nitrogen) During Treatment. | Participants with available data at the respective time point | Posted | Mean | Standard Error | mg/dL | baseline to 4-week, 8-week, and 12-week |
|
|
|
| Secondary | Change From Baseline on Blood Clinical Labs (Calcium) During Treatment. | Participants with available data at the respective time point | Posted | Mean | Standard Error | mg/dL | baseline to 4-week, 8-week, and 12-week |
|
|
|
| Secondary | Change From Baseline on Blood Clinical Labs (Osmolality) During Treatment. | Participants with available data at the respective time point | Posted | Mean | Standard Error | mOsm/kg | baseline to 4-week, 8-week, and 12-week |
|
|
|
| Secondary | Change From Baseline on Urine Clinical Labs (Osmolality) During Treatment. | Participants with available data at the respective time point | Posted | Mean | Standard Error | mOsm/kg | baseline to 4-week, 8-week, and 12-week |
|
|
|
| Secondary | Change From Baseline on Vital Signs (Systolic Blood Pressure) During Treatment. | Participants with available data at the respective time point | Posted | Mean | Standard Error | mmHg | Up to 12 weeks |
|
|
|
| Secondary | Change From Baseline on Vital Signs (Diastolic Blood Pressure) During Treatment. | Participants with available data at the respective time point | Posted | Mean | Standard Error | mmHg | Up to 12 weeks |
|
|
|
| Secondary | Change From Baseline on Vital Signs (Pulse) During Treatment. | Participants with available data at the respective time point | Posted | Mean | Standard Error | beats per minute (BPM) | Up to 12 weeks |
|
|
|
| Secondary | Change From Baseline on Height During Treatment. | Participants with available data at the respective time point | Posted | Mean | Standard Error | cm | baseline to 4-week, 8-week, and 12-week |
|
|
|
| Secondary | Change From Baseline on Weight During Treatment. | Participants with available data at the respective time point | Posted | Mean | Standard Error | kg | baseline to 4-week, 8-week, and 12-week |
|
|
|
| Secondary | Change From Baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) During Treatment. | The DOTES evaluates a subset of symptoms related to various medical conditions. The clinician assesses intensity (0=Not assessed, 1=Not present, 2=Mild, 3=Moderate, 4=Severe), relatedness (0=None, 1=Remote, 2=Possible, 3=Probable, 4=Defined), and action taken (0=None, 1=Increased , 2=Contractive Rx, 3=Change Dose, 4=Change Dose Plus Contractive Rx, 5=Suspend Rx, 6=Discontinue Rx). Side effects are included that have increased in severity, become more likely to be related, or require action. Change from baseline is reported as the number of participants with change in these side effects during treatment. | Participants with available data at the respective time point | Posted | Count of Participants | Participants | Up to 12 weeks |
|
|
|
| Secondary | Number of Participants Reporting Aggression Using the Overt Aggression Scale (OAS) During Treatment. | The scale evaluates the child participant's aggression. The number of children who exhibited aggression as reported by the parent is reported. | Participants with available data at the respective time point. | Posted | Count of Participants | Participants | baseline, 4-weeks, 8-weeks |
|
|
|
| Secondary | Adverse Event Severity | Adverse events collated according to intensity for each pre-allocated treatment group. | Posted | Count of Participants | Participants | Up to 12 weeks |
|
|
|
| Other Pre-specified | Baseline Vasopressin Concentration Predicting Primary and Secondary Behavioral Outcome Measures. | Not Posted | 4-week; 8-week | Participants |
| Other Pre-specified | Change From Baseline in Vineland Adaptive Behavior Scales, Third Edition (VABS-3) - Social Skills and Relationships Domain During Treatment. | Not Posted | 4-week; 8-week | Participants |
| Other Pre-specified | Change From Baseline in Parent Rated Pediatric Quality of Life (PedsQL) Inventory Scores During Treatment. | Not Posted | 4-week; 8-week | Participants |
| Other Pre-specified | Change From Baseline on Eye Gaze Assessment (Eye Tracking) During Treatment. | Not Posted | 4-week; 8-week | Participants |
| Other Pre-specified | Change From Baseline on the Developmental Neuropsychological Assessment, Second Edition (NEPSY-II) Theory of Mind Test During Treatment. | Not Posted | 4-week; 8-week | Participants |
| Other Pre-specified | Change From Baseline the Diagnostic Analysis of Nonverbal Accuracy, Second Edition (DANVA-2) Child Voices Prosody Test During Treatment. | Not Posted | 4-week; 8-week | Participants |
| Other Pre-specified | Change From Baseline in Parent Rated Stanford Social Motivation Scale (Also Known as the Stanford Social Dimensional Scale) Total Scores During Treatment. | Not Posted | 4-week; 8-week | Participants |
| Other Pre-specified | Change From Baseline in Parent Rated Anxiety Scale - Autism Spectrum Disorder (PRAS-ASD) Score During Treatment. | Not Posted | 4-week; 8-week | Participants |
| Other Pre-specified | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Social Avoidance Factor Score During Treatment. | Not Posted | 4-week; 8-week | Participants |
| Other Pre-specified | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Emotion Recognition Factor Score During Treatment. | Not Posted | 4-week; 8-week | Participants |
| Other Pre-specified | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Interpersonal Relatedness Factor Score During Treatment. | Not Posted | 4-week; 8-week | Participants |
| Other Pre-specified | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Insistence On Sameness Factor Score During Treatment. | Not Posted | 4-week; 8-week | Participants |
| Other Pre-specified | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Repetitive Mannerisms Factor Score During Treatment. | Not Posted | 4-week; 8-week | Participants |
| Other Pre-specified | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Attachment and Affiliation Factor Score During Treatment. | Not Posted | 4-week; 8-week | Participants |
| Other Pre-specified | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Non-facial Communication Production Factor Score During Treatment. | Not Posted | 4-week; 8-week | Participants |
| Other Pre-specified | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Facial Communication Production Factor Score During Treatment. | Not Posted | 4-week; 8-week | Participants |
| Other Pre-specified | Change From Baseline in Parent Rated Social Responsiveness Scale, Second Edition (SRS-2) Mental States Understanding Factor Score During Treatment. | Not Posted | 4-week; 8-week | Participants |
| Other Pre-specified | Change From Baseline in Parent Rated Child's Sleep Habits Questionnaire (CSHQ) Score During Treatment. | Not Posted | 4-week; 8-week | Participants |
| Other Pre-specified | Change From Baseline on Spectral Power in the Alpha, Theta, and Gamma Frequencies as Measured by Electroencephalogram (EEG) During Treatment. | Not Posted | 4-week; 8-week | Participants |
| 0 |
| 22 |
| 0 |
| 22 |
| 12 |
| 22 |
| EG001 | Placebo-Vasopressin Group - Treatment Period 1 | Adverse events occurring in the Placebo-Vasopressin group during the first 4-week treatment period (while receiving placebo). | 0 | 42 | 0 | 42 | 31 | 42 |
| EG002 | Placebo-Placebo Group - Treatment Period 1 | Adverse events occurring in the Placebo-Placebo group during the first 4-week treatment period (while receiving placebo). | 0 | 39 | 0 | 39 | 29 | 39 |
| EG003 | Vasopressin-Vasopressin Group - Treatment Period 2 | Adverse events occurring in the Vasopressin-Vasopressin group during the second 4-week treatment period (while receiving active drug). | 0 | 21 | 0 | 21 | 15 | 21 |
| EG004 | Placebo-Vasopressin Group - Treatment Period 2 | Adverse events occurring in the Placebo-Vasopressin group during the second 4-week treatment period (while receiving active drug). | 0 | 38 | 0 | 38 | 24 | 38 |
| EG005 | Placebo-Placebo Group - Treatment Period 2 | Adverse events occurring in the Placebo-Placebo group during the second 4-week treatment period (while receiving placebo). | 0 | 39 | 0 | 39 | 26 | 39 |
| EG006 | Open-label Vasopressin | Adverse events occurring in the Placebo-Placebo group during the open-label extension (after the 2 initial treatment periods, while receiving active drug). | 0 | 32 | 0 | 32 | 20 | 32 |
| Earache | Ear and labyrinth disorders | Systematic Assessment |
|
| Dilated Pupils | Eye disorders | Systematic Assessment |
|
| Eye Redness | Eye disorders | Systematic Assessment |
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| Eyelid Edema | Eye disorders | Systematic Assessment |
|
| Hordeolum | Eye disorders | Systematic Assessment |
|
| Lacrimation Increased | Eye disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
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| Fecal Incontinence | Gastrointestinal disorders | Systematic Assessment |
|
| Flatuence | Gastrointestinal disorders | Systematic Assessment |
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| Pharyngeal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Saliva Hypersecretion | Gastrointestinal disorders | Systematic Assessment |
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| Throat Burning Sensation | Gastrointestinal disorders | Systematic Assessment |
|
| Tooth Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting or Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Seasonal Allergy | Immune system disorders | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Ear Infection | Infections and infestations | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Increased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Muscle Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Agitation | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Initial Insomnia | Nervous system disorders | Systematic Assessment |
|
| Middle Insomnia | Nervous system disorders | Systematic Assessment |
|
| Sedation | Nervous system disorders | Systematic Assessment |
|
| Somnolence | Nervous system disorders | Systematic Assessment |
|
| Unspecified Insomnia | Nervous system disorders | Systematic Assessment |
|
| Aggression | Psychiatric disorders | Systematic Assessment |
|
| Anal Picking | Psychiatric disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Depressed Mood | Psychiatric disorders | Systematic Assessment |
|
| Echopraxia | Psychiatric disorders | Systematic Assessment |
|
| Finger Sucking | Psychiatric disorders | Systematic Assessment |
|
| Hyperactivity | Psychiatric disorders | Systematic Assessment |
|
| Impulsive Behavior | Psychiatric disorders | Systematic Assessment |
|
| Inappropriate Sexual Behavior | Psychiatric disorders | Systematic Assessment |
|
| Inattention | Psychiatric disorders | Systematic Assessment |
|
| Irritability or Anger | Psychiatric disorders | Systematic Assessment |
|
| Nail Biting | Psychiatric disorders | Systematic Assessment |
|
| Nightmares | Psychiatric disorders | Systematic Assessment |
|
| Psychomotor Retardation | Psychiatric disorders | Systematic Assessment |
|
| Screaming | Psychiatric disorders | Systematic Assessment |
|
| Wandering Behavior | Psychiatric disorders | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Systematic Assessment |
|
| Enuresis | Renal and urinary disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Gag Reflex Abnormal | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal Discomfort | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal Pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nose Bleed | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Runny Nose | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Snoring | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dysmenorrhea | Reproductive system and breast disorders | Systematic Assessment |
|
| Bug Bite | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Scratch | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| CGI-S score - change from baseline at 4-week |
|
|
| CGI-S score - 4-week |
|
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| CGI-S score - change from 4-week at 8-week |
|
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| CGI-I: 4-week (end of treatment period 1) |
|
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| CGI-I: 8-week (end of treatment period 2) |
|
|
| Change from baseline at 4-week |
|
|
| 4-week |
|
|
| Change from 4-week at 8-week |
|
|
| Change from baseline at 4-week |
|
|
| 4-week |
|
|
| Change from 4-week at 8-week |
|
|
| Change from baseline at 4-week |
|
|
| 4-week |
|
|
| Change from 4-week at 8-week |
|
|
| Change from baseline at 4-week |
|
|
| 4-week |
|
|
| Change from 4-week at 8-week |
|
|
| 4-weeks (end of treatment period 1) |
|
|
| 8-weeks (end of treatment period 2) |
|
|
| 12-weeks (end of open-label extension) |
|
|
| 4-weeks (end of treatment period 1) |
|
|
| 8-weeks (end of treatment period 2) |
|
|
| 12-weeks (end of open-label extension) |
|
|
| 4-weeks (end of treatment period 1) |
|
|
| 8-weeks (end of treatment period 2) |
|
|
| 12-weeks (end of open-label extension) |
|
|
| 4-weeks (end of treatment period 1) |
|
|
| 8-weeks (end of treatment period 2) |
|
|
| 12-weeks (end of open-label extension) |
|
|
| 4-weeks (end of treatment period 1) |
|
|
| 8-weeks (end of treatment period 2) |
|
|
| 12-weeks (end of open-label extension) |
|
|
| 4-weeks (end of treatment period 1) |
|
|
| 8-weeks (end of treatment period 2) |
|
|
| 12-weeks (end of open-label extension) |
|
|
| 4-weeks (end of treatment period 1) |
|
|
| 8-weeks (end of treatment period 2) |
|
|
| 12-weeks (end of open-label extension) |
|
|
| 4-weeks (end of treatment period 1) |
|
|
| 8-weeks (end of treatment period 2) |
|
|
| 12-weeks (end of open-label extension) |
|
|
| 4-weeks (end of treatment period 1) |
|
|
| 8-weeks (end of treatment period 2) |
|
|
| 12-weeks (end of open-label extension) |
|
|
| 4-weeks (end of treatment period 1) |
|
|
| 8-weeks (end of treatment period 2) |
|
|
| 12-weeks (end of open-label extension) |
|
|
| 4-weeks (end of treatment period 1) |
|
|
| 8-weeks (end of treatment period 2) |
|
|
| 12-weeks (end of open-label extension) |
|
|
| 4-weeks (end of treatment period 1) |
|
|
| 8-weeks (end of treatment period 2) |
|
|
| 12-weeks (end of open-label extension) |
|
|
| 4-weeks (end of treatment period 1) |
|
|
| 8-weeks (end of treatment period 2) |
|
|
| 12-weeks (end of open-label extension) |
|
|
| 4-weeks (end of treatment period 1) |
|
|
| 8-weeks (end of treatment period 2) |
|
|
| 12-weeks (end of open-label extension) |
|
|
| 4-weeks (end of treatment period 1) |
|
|
| 8-weeks (end of treatment period 2) |
|
|
| 12-weeks (end of open-label extension) |
|
|
| Standing |
|
| Change from standing to sitting |
|
| Standing |
|
| Change from standing to sitting |
|
| Standing |
|
| Change from standing to sitting |
|
| 4-weeks (end of treatment period 1) |
|
|
| 8-weeks (end of treatment period 2) |
|
|
| 12-weeks (end of open-label extension) |
|
|
| 4-weeks (end of treatment period 1) |
|
|
| 8-weeks (end of treatment period 2) |
|
|
| 12-weeks (end of open-label extension) |
|
|
| Constipation |
|
| Diarrhea |
|
| Dry Mouth |
|
| Saliva Hypersecretion |
|
| Vomiting or Nausea |
|
| Decreased Appetite |
|
| Increased Appetite |
|
| Agitation |
|
| Headache |
|
| Initial Insomnia |
|
| Middle Insomnia |
|
| Unspecified Insomnia |
|
| Aggression |
|
| Depressed Mood |
|
| Hyperactivity |
|
| Nasal Congestion |
|
| Pruritus |
|
| Rash |
|
| 4-weeks |
|
|
| 8-weeks |
|
|
| Moderate |
|
| Severe |
|
| Life-threatening |
|
| Death |
|